Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications

Phase 2CompletedNCT02094118

Mayo Clinic171 enrolled

Overview

This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

171

Conditions

Blood Transfusion Complications

Interventions

Point-of-care washed red blood cell transfusion.BIOLOGICAL

Standard of care red blood cell transfusion.BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age equal to or greater than 18 years of age. * Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina * At risk for needing at least 4 units of blood during/after surgery Exclusion Criteria: * Emergency surgery * Immunoglobulin A (IgA) deficiency * History of severe recurrent transfusion reactions * Refusal to receive allogeneic blood products * Refusal to provide informed consent * Prevalent lung injury prior to randomization * Prevalent congestive heart failure prior to randomization * Expected hospital stay \< 48 hours * Not anticipated to survive \> 48 hours * Previously enrolled in this trial * No plan for placement of a pulmonary artery catheter * Use of home oxygen therapy * Complex RBC antibody profiles * Need for the use of irradiated RBCs

Locations (2)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.

This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.

Time frame: 18 hours after the initiation of the first red blood cell transfusion.

Number of "Off-protocol" Transfusions

The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion.

Time frame: Day of surgery. Approximately 1 day.

Change in Recipient Hemoglobin

Change in Hemoglobin from pre-transfusion to post-transfusion

Time frame: Pre to 6 hours post transfusion

Change in Recipient Cell Free Hemoglobin(CFH)

Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion

Time frame: Pre transfusion until study day 5 or hospital discharge, approximately 5 days

Change in Haptoglobin

Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion

Time frame: Pre transfusion to study day 5 or hospital discharge, approximately 5 days

Secondary Outcomes

Duration of Mechanical Ventilation

Number of hours subject received mechanical ventilation.

Time frame: Up to hospital day 28, or discharge, whichever comes first

Data from ClinicalTrials.gov

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